Primary Device ID | 00841436108621 |
NIH Device Record Key | b7f7611f-96cb-41a5-b158-38d435ecdfa9 |
Commercial Distribution Discontinuation | 2019-01-16 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | System Drape |
Version Model Number | DR-000537 |
Catalog Number | DR-000537 |
Company DUNS | 134614411 |
Company Name | CIVCO MEDICAL INSTRUMENTS CO., INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com | |
Phone | +1(319)248-6502 |
regulatory@civco.com |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Width | 45.7 Centimeter |
Length | 73.7 Centimeter |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841436108621 [Package] Contains: 10841436108628 Package: [10 Units] Discontinued: 2019-01-16 Not in Commercial Distribution |
GS1 | 10841436108628 [Primary] |
ITX | Transducer, ultrasonic, diagnostic |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
[00841436108621]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-09-03 |
Device Publish Date | 2017-08-22 |
00841436120906 | Non-sterile (81.3x91.4cm) polyethlene drape |
00841436120869 | Non-sterile (76x76cm) polyethlene drape |
00841436108621 | Sterile polyethylene instrument drape for use with NeuWave Certus 140 PDM |
00841436101417 | Sterile (76 x 76cm) polyethylene drape |
00841436110426 | Sterile (81 x 91cm) polyethylene drape |
00841436104296 | Sterile polyethylene drape (81.3 x 91.4cm) for use with AccuCARE Positioning and Stabilizing equ |
00841436104029 | Sterile (11.9 tapered to 4.9 x 55.6cm) CIV-Flex™ cover for use with Mammotome EX and SenoRX En |